Review Mechanisms for Advanced Medical Therapies in Japan and Thailand: A Proposal for the Use of Expert Clinical Benefit Assessments at Designated Institutions
Issued Date
2024-01-01
Resource Type
ISSN
17938759
eISSN
17939453
Scopus ID
2-s2.0-85201298757
Journal Title
Asian Bioethics Review
Rights Holder(s)
SCOPUS
Bibliographic Citation
Asian Bioethics Review (2024)
Suggested Citation
Matsui K., Israsena N., Kaewkungwal J., Adams P., Wendler D., Lie R.K. Review Mechanisms for Advanced Medical Therapies in Japan and Thailand: A Proposal for the Use of Expert Clinical Benefit Assessments at Designated Institutions. Asian Bioethics Review (2024). doi:10.1007/s41649-024-00301-9 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/100705
Title
Review Mechanisms for Advanced Medical Therapies in Japan and Thailand: A Proposal for the Use of Expert Clinical Benefit Assessments at Designated Institutions
Author(s)
Corresponding Author(s)
Other Contributor(s)
Abstract
Advanced new therapies, such as stem cell and gene therapies and xenotransplantation, represent challenges for regulatory and ethical review. Major drug agencies, such as in the U.S., India, and Europe, have asserted regulatory authority and require ethics review by local ethics review committees, using the same strict requirements as those for standard drug approvals. In spite of this, unapproved and undocumented stem cell clinics flourish in all of these places, suggesting that current approaches do not offer patients sufficient protection. Japan has attempted another approach, requiring approvals at local levels for all regenerative medical procedures, and a faster approval of promising new interventions. The Japanese approach has, however, also been criticized as not striking a proper balance between early access and a proper assessment of safety and effectiveness. For smaller and less-resourced countries, such as Thailand, one major challenge is limited expertise to conduct the evaluation of these advanced new therapies. This article provides an overview of the issues facing regulators and proposes that countries should restrict the early adoption of advanced new therapies to specialized clinics with appropriate scientific and ethical expertise for review. Review in these institutions should focus on expert clinical benefit assessments for individual patients being offered such interventions, independently of whether they are offered as research or therapy.